FDA records indicate that there are no current recalls for this drug.
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Cocaine Hydrochloride Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.
Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available.
Animal reproduction studies have not been conducted with cocaine. It is also not known whether cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cocaine hydrochloride topical solution is indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.
History
There is currently no drug history available for this drug.
Other Information
Each mL contains:
Cocaine hydrochloride 40 mg or 100 mg As aqueous solution.
The topical solution contains the following inactive ingredients: citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and water.
NOTE (for Glass Bottle): External surface of unopened bottle may be sterilized by ethylene oxide only. Do not steam autoclave.
Cocaine hydrochloride USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine hydrochloride is a local anesthetic.
Sources
Cocaine Hydrochloride Solution Manufacturers
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Lannett Company, Inc.
Cocaine Hydrochloride Solution | Lannett Company, Inc.
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Cocaine hydrochloride topical solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.
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